Singlon, pills 4mg, 28pcs

Composition

1 tablet contains montelukast 4 mg

Pharmacological action

Singlon is a blocker of cysteinyl leukotriene receptors CysLT1 (leukotrienes C4, D4 and E4 are mediators of chronic persistent inflammation that supports bronchial hyperreactivity in bronchial asthma). Prevents excessive secretion in the bronchi, swelling of the mucous membrane of the respiratory tract. Reduces the severity of bronchial asthma and the frequency of asthmatic attacks. Highly effective when taken orally. The bronchodilator effect develops within 1 day and persists for a long time. It is effective in patients with mild persistent asthma that is not sufficiently controlled by bronchodilators alone.

Indications

Bronchial asthma (prevention and long-term treatment), complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis and intolerance to ASA or other NSAIDs (including in the anamnesis), physical exertion bronchial asthma, alloretic rhinitis.

Contraindications

Hypersensitivity, children’s age (up to 6 years). With caution. Pregnancy and lactation.

Side effects

from the blood coagulation system:  increased tendency to bleed.

From the immune system:  hypersensitivity reactions, including anaphylaxis; very rare (

From the side of the psyche:  agitation (including aggressive behavior or hostility), anxiety, depression, disorientation, abnormal dreams, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thoughts and behavior( suicidality), tremor.

Nervous system disorders:  dizziness, drowsiness, paresthesia/hypesthesia; very rare (

From the cardiovascular system:  tachycardia.

Respiratory system disorders:  nosebleeds, upper respiratory tract infections.

From the digestive system:  diarrhea, dyspepsia, nausea, vomiting, pancreatitis, increased ALT and ACT activity in the blood; very rare (

Skin and subcutaneous tissue disorders:  tendency to form hematomas, erythema nodosum, erythema multiforme, pruritus, rash.

Allergic reactions:  angioedema, urticaria.

Musculoskeletal disorders:  arthralgia, myalgia, including muscle cramps.

From the body as a whole:  asthenia (weakness)/fatigue, swelling, pyrexia.

Interaction

When used concomitantly with phenobarbital, the AUC of montelukast decreased by approximately 40% (correction of the montelukast regimen is not required).

In vitro studies have shown that montelukast inhibits the CYP2C8 isoenzyme, but the study of the in vivo drug interaction between montelukast and rosiglitazone (metabolized with the participation of the CYP2C8 isoenzyme ) did not confirm the inhibition of the CYP2C8 isoenzyme by montelukast. Therefore, in clinical practice, montelukast is not expected to affect the CYP2C8-mediated metabolism of a number of drugs, including paclitaxel, rosiglitazone, and repaglinide.

Montelukast is a reasonable adjunct to monotherapy with bronchodilators, if the latter do not provide adequate control of bronchial asthma. After achieving the therapeutic effect of treatment with montelukast, you can start gradually reducing the dose of bronchodilators.

The use of montelukast provides an additional therapeutic effect in patients receiving inhaled corticosteroids. When the condition is stabilized, you can start gradually reducing the dose of corticosteroids under the supervision of a doctor. In some cases, complete withdrawal of inhaled corticosteroids is acceptable, but abrupt replacement of inhaled corticosteroids with montelukast is not recommended.

How to take, course of use and dosage

Singlon is taken orally, regardless of food intake. Adults and adolescents over 15 years of age – 10 mg 1 time a day, before bedtime. Children 6-14 years – 4 mg/day.

Overdose

There is no specific information on the treatment of overdose with Singlon. There are no data on overdose symptoms when taking the drug in adult patients with bronchial asthma at a dose exceeding 200 mg / day. for 22 weeks and at a dose of 900 mg / day. it was not detected within 1 week. There have been cases of acute overdose of montelukast in adults and children at a dose higher than 1000 mg (approximately 61 mg / kg for a child aged 42 months). The obtained clinical and laboratory results were consistent with the safety profile for adults and children. The most common adverse events were consistent with the safety profile of montelukast and included abdominal pain, drowsiness, mydriasis, thirst, headache, vomiting, and psychomotor hyperactivity. There are no data on the possibility of elimination of montelukast during peritoneal dialysis or hemodialysis.

Special instructions

The efficacy of oral montelukast for the treatment of acute asthma attacks has not been established. Therefore, montelukast for oral use is not recommended for the treatment of acute attacks of bronchial asthma. Patients should be instructed to always carry emergency medications for managing asthma attacks (short-acting inhaled beta-2 agonists).

Do not stop taking montelukast during the period of acute asthma and the need to use emergency medications (short-acting inhaled beta-2 agonists) to stop seizures.

Patients with confirmed allergies to acetylsalicylic acid and other NSAIDs should not take these medications during treatment with montelukast, since montelukast, while improving respiratory function in patients with allergic bronchial asthma, cannot completely prevent their NSAID-induced bronchoconstriction.

The dose of inhaled corticosteroids used simultaneously with montelukast can be gradually reduced under the supervision of a doctor, but a sharp replacement of inhaled or oral corticosteroids with montelukast should not be carried out.

Neuropsychiatric disorders have been reported in patients treated with montelukast. Given that these symptoms may have been caused by other factors, it is not known whether they are related to taking montelukast. The doctor should discuss these side effects with patients and/or their parents / guardians. Patients and/or their caregivers should be advised that if such symptoms occur, they should inform the attending physician.

Reducing the dose of systemic corticosteroids in patients receiving anti-asthmatic agents, including leukotriene receptor blockers, was accompanied in rare cases by one or more of the following reactions: eosinophilia, rashes, worsening of pulmonary symptoms, cardiac complications and/or neuropathy, sometimes diagnosed as Charge-Strauss syndrome, systemic eosinophilic vasculitis. Although the causal relationship of these adverse reactions with leukotriene receptor antagonist therapy has not been established, caution should be exercised and appropriate clinical monitoring should be carried out when reducing the dose of systemic corticosteroids in patients receiving montelukast.

Storage conditions

Keep the drug out of the reach of children, dry and protected from light at a temperature not exceeding 25°C.

Shelf life

2 years

Active ingredient

Montelukast

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

Adults as prescribed by a doctor, Children as prescribed by a doctor, Children over 2 years of age

Indications

Bronchospasm, Bronchial asthma